Cleared Traditional

K151004 - PULLUP Adjustable Juxtacortical Fixatio...

K151004 is the FDA 510(k) clearance for PULLUP Adjustable Juxtacortical Fixatio... by Sbm Sciences For Bio Materials. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K151004 · Sbm Sciences For Bio Materials · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
216d
Days
Class 2
Risk

K151004 is an FDA 510(k) clearance for the PULLUP® Adjustable Juxtacortical Fixation Device. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Sbm Sciences For Bio Materials (Lourdes, FR). The FDA issued a Cleared decision on November 17, 2015 after a review of 216 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sbm Sciences For Bio Materials devices

Submission Details

510(k) Number K151004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date November 17, 2015
Days to Decision 216 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 122d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K151004.
Adjustable Fixation Device
K153186 · Arthrocare Corp. · Jan 2016
SpeedLock Knotless Fixation System
K153313 · ArthroCare Corporation · Dec 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
K152566 · Smith & Nephew, Inc. · Dec 2015
JuggerKnot Soft Anchors
K150768 · Biomet Manufacturing Corp · Sep 2015
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
K150648 · Arthrex, Inc. · Aug 2015
MultiFIX® P Knotless Fixation Device
K151897 · ArthroCare Corporation · Aug 2015